UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056317 |
|---|---|
| Receipt number | R000064345 |
| Scientific Title | Verification of the effect of sound characteristics on mood |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/29 19:29:14 |
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Basic information
Public title
Verification of the effect of sound characteristics on mood
Acronym
Verification of the effect of sound characteristics on mood
Scientific Title
Verification of the effect of sound characteristics on mood
Scientific Title:Acronym
Verification of the effect of sound characteristics on mood
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the mood (anxiety, agitation, excitement, and lethargy) of healthy adult subjects as relief or anxiety and concentration as indicators of different sound frequencies by objective and subjective evaluation, as a preliminary step in considering music therapy for patients with dementia. The objective evaluation is made by Open Face and electroencephalography, and the subjective evaluation is made by the multiple mood scale.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Depression and anxiety, Concentration in the Mood Assessment Questionnaire using the Multidimensional Affective State Scale
Key secondary outcomes
1.Various parameters of facial muscle movements (Action Unit: AU) measured by OpenFace
2.Measurement of alpha and beta waves using a patch electroencephalograph
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Music by organ with many frequency components
Interventions/Control_2
Music by piano with medium frequency components
Interventions/Control_3
Music by recorder with low frequency component
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult men and women between the ages of 18 and 30 who agree with the main purpose of this study.
Those who can tolerate alcohol to the level of alcohol disinfection.
Those who do not experience allergic reactions such as rashes caused by tapes or gels.
Key exclusion criteria
People with hearing loss
People who have difficulty with music
People who cannot take facial images with eyebrows out for some reason
People with a history of depression
People who have difficulty listening to music through headphones
People with skin disorders in the frontal area or those with fragile frontal skin
People who have scars or inflammation on the frontal area
People who use a defibrillator or pacemaker
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
2-746, Asahimachi-dori, Chuo-ku, Niigata city, Japan
TEL
+81252270941
sakai@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
2-746, Asahimachi-dori, Chuo-ku, Niigata city, Japan
TEL
+81252270941
Homepage URL
sakai@clg.niigata-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata City ,Japan
Tel
+8525-227-2625
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064345
